An interventional study of Move-MORE in Lumbosacral Radiculopathy, Sciatica and Chronic Low Back Pain With a Neuropathic Component, sponsored by National University of Natural Medicine. Recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by National University of Natural Medicine · Not applicable, Interventional, and Treatment
The Move-MORE study is designed to evaluate a multicomponent mindfulness and movement program for patients with lumbosacral radiculopathy. The program brings together mindfulness training to help participants develop awareness of their body and manage pain-related stress, gentle movement practice to improve comfort with physical activity and support function, and motivational interviewing to strengthen motivation, confidence, and the ability to make healthy changes.
The main objectives are to determine whether it is feasible for participants to use each component of the program when delivered online, to assess how acceptable and engaging each component is, and to evaluate the impact on pain, physical function, and daily activity levels. The study intervention will be conducted entirely remotely. Participants will complete online surveys, brief daily check-ins on their phone, and wear a small activity monitor on the hip to measure movement. They will also undergo quantitative sensory testing to evaluate pain sensitivity. At the end of the program, participants will share feedback about their experiences via qualitative interviews.
The findings will help identify which parts of the program provide the greatest benefit, with the ultimate goal of developing a more targeted and effective digital program for people with this condition.
Lumbosacral radiculopathy (LR) is a spinal pathology that manifests as pain, weakness, and numbness in the lower extremity. Commonly referred to as "sciatica", LR has a lifetime prevalence up to 43%, and can often become an intractable condition with long-term outcomes unimproved by conventional biomedical treatments such as surgery. Thus, we seek to develop a non-invasive and non-pharmacologic treatment for LR patients
This study aims to 1) develop a multicomponent intervention that integrates Mindfulness-Oriented Recovery Enhancement and physical activity for patients with LR, 2) assess the feasibility and acceptability of this multicomponent intervention, and 3) evaluate preliminary efficacy of the intervention via self-report measures of pain, disability, kinesiophobia, and other psychosocial factors related to chronic pain. In addition, this study will use quantitative sensory testing (i.e., pressure and heat pain thresholds) as an objective measure of pain.
The multicomponent intervention will be developed (AIM 1) using qualitative data from focus groups of LR patients and semi-structured interviews from a multidisciplinary sample of physicians who treat LR. This data will be analyzed using a thematic approach to assess barriers and facilitators to participation, patients' perspectives on non-pharmacologic interventions, and physicians' views of medically necessary considerations. Qualitative findings will be presented to a team of expert mindfulness instructors to support program design. In a single arm trial designed to assess feasibility, acceptability, and preliminary efficacy of the intervention (AIMS 2 and 3), we will administer the multicomponent program developed in Aim 1. Data will be collected from participants at three time points: baseline, midpoint, post-intervention, 3-month follow-up. In addition, ratings of pain intensity will be captured daily via ecologic momentary assessment.
During the intervention period, participants will be asked to attend virtual classes once a week. Between weekly sessions, participants will also be asked to track their home practice, daily levels of pain, and any adverse events via a daily survey. At the end of the study, participants will be asked to participate in a semi-structured exit interview which will inquire about their experience in the intervention.
This study seeks to shift the current research paradigm by being the first to develop and test a novel non-invasive, non-pharmacologic, multicomponent intervention for LR. As such, the proposed research contributes much needed scientific knowledge toward identifying efficacious treatments for a highly prevalent, costly, and intractable condition.
149 studies on the registry are indexed under Sciatica; 31 are open to participants now.
This study's planned enrollment of 32 is below the median of 68 across 122 interventional studies indexed under Sciatica.
Browse Sciatica studies →National University of Natural Medicine is the lead sponsor of 39 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Tampa Scale of Kinesiophobia score ≥ 23. If TSK \< 23, the participant must endorse at least two of the following experiences in the past month on a structured cognitive interview:
At least one positive physical examination finding consistent with lumbosacral radiculopathy, including at least one of the following:
Neurological deficit in a lumbar nerve root distribution, including at least one of the following:
Exclusion criteria
Participants will be excluded if they have clinical signs or symptoms of lumbosacral radiculopathy with progressive neurologic deficits (loss of motor or sensory function) or intolerable pain.
o Participants with lumbosacral radiculopathy with progressive neurologic deficits will be referred for immediate medical attention, and are not eligible for participation in this study.
Participants will be excluded if they have clinical signs or symptoms suggestive of cauda equina syndrome, including any of the following:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will go through the multicomponent Move-MORE program. Move-MORE is an integrated mind-body intervention which combines mindfulness, physical activity, and motivational interviewing informed by the principles of self-determination theory
Behavioral: Move-MORE
Move-MORE is a multicomponent intervention which combines mindfulness training, physical activity, and motivational interviewing informed by the principles of self-determination theory. The version of Move-MORE being used in this study is specifically designed for use in patients with lumbosacral radiculopathy.
Recruitment Proportion
The proportion of patients contacted who consent to screening
Time frame: End of study
Retention
Retention will be assessed by tracking the percentage of participants who complete their primary endpoint visit
Time frame: End of study
Client Satisfaction Questionnaire
Intervention Satisfaction. Min = 8, Max = 32. Higher score = greater satisfaction.
Time frame: Week 4, Week 8, Week 20
Adherence
The proportion of participants completing at least 5 intervention sessions
Time frame: End of study
Adverse Events
The frequency and severity of adverse events (AEs) and serious adverse events (SAEs) occurring during the study.
Time frame: End of study
Intervention Satisfaction
Satisfaction will be measured using the Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 is a self-report measure designed to assess satisfaction with health services.
Time frame: Week 4, Week 8
Oswestry Disability Index
Activities of daily living. Min = 0%, Max = 100%. Higher score = worse outcomes.
Time frame: Week 0, Week 4, Week 8, Week 20
painDETECT Questionnaire
Neuropathic Pain. Min = -1, Max = 38. Higher score = worse outcomes.
Time frame: Week 0, Week 4, Week 8, Week 20
Visual Analog Scale
Pain Intensity. Min = 0, Max = 10. Higher score = worse pain
Time frame: Daily
Complex Medical Symptoms Inventory
A questionnaire to assess pain hypersensitivity and allodynia. The CMSI inquires about participants' pain experiences specifically related to hypersensitivity and allodynia to discern whether an individual may experience central sensitization. Currently, no direct measures of self-reported nociplastic pain exist, thus measures of central sensitization can be used as surrogate measures for this construct. The CSI has previously been shown to have strong test-retest reliability in chronic pain patients.
Time frame: Week 0, Week 4, Week 8, Week 20
Nociplastic Pain Questionnaire
The NPQ is a screening tool designed to identify characteristics of nociplastic pain, which arises from altered nociception without clear evidence of tissue damage or somatosensory system disease. The NPQ assesses symptoms such as widespread pain, fatigue, sleep disturbance, and cognitive difficulties, helping to differentiate nociplastic pain from nociceptive and neuropathic pain mechanisms.
Time frame: Week 0, Week 4, Week 8, Week 20
Patient Global Impression of Change
The PGIC is a single-item, patient-reported outcome measure that captures a participant's overall perception of improvement or decline in health status since the start of an intervention. Rated on a 7-point Likert scale ranging from "very much improved" to "very much worse," the PGIC provides a global assessment of treatment effectiveness from the patient's perspective.
Time frame: Week 0, Week 4, Week 8, Week 20
Healthcare Utilization Changes
This questionnaire will assess whether participants have changed their use or plans for use of pain medication, injection, nerve ablation, or surgery as a result of participation in the study.
Time frame: Week 4, Week 8, Week 20
The Pain, Enjoyment of Life and General Activity (PEG-3)
The PEG-3 is a brief, 3-item measure derived from the Brief Pain Inventory that assesses pain intensity and its impact on enjoyment of life and general activity. Each item is rated on a 0-10 scale, with higher scores indicating greater pain-related interference. The PEG-3 is a validated tool commonly used in both clinical and research settings to monitor pain outcomes efficiently.
Time frame: Week 0, Week 4, Week 8, Week 20
Tampa Scale of Kinesiophobia (TSK-11)
A questionnaire to assess fear of movement. The TSK-11 is designed to assess the presence of fear of movement. This measure has previously been validated in populations of patients with chronic non-specific low back pain and shown to have good reliability.
Time frame: Week 0, Week 4, Week 8, Week 20
Pain Catastrophizing Scale (PCS)
A questionnaire to assess pain catastrophizing and rumination. The PCS is ubiquitously used to assess pain catastrophizing via its subscales: helplessness, rumination, and magnification. It has primarily been used and validated in patients with low back pain.
Time frame: Week 0, Week 4, Week 8, Week 20
PROMIS Self-Efficacy for Managing Symptoms 8a
The PROMIS Self-Efficacy for Managing Symptoms 8a is an 8-item patient-reported measure assessing an individual's confidence in managing symptoms related to their health conditions. It evaluates domains such as controlling symptoms, performing tasks despite symptoms, and coping with the impact of symptoms on daily life. Higher scores indicate greater self-efficacy in symptom management. This tool helps capture patients' perceived ability to handle their health challenges and is useful for tailoring interventions and tracking progress in clinical research.
Time frame: Week 0, Week 4, Week 8, Week 20
PROMIS Ability to Participate in Social Roles
A questionnaire to assess social participation. The ability to participate in social roles questionnaire is a PROMIS measure designed to evaluate the impact of a condition on social engagement. It has previously been validated with an additional questionnaire, satisfaction with participation in social activities.
Time frame: Week 0, Week 4, Week 8, Week 20
PROMIS Sleep Disturbance 6a + Sleep Duration Question
This is a validated patient-reported outcome measure assessing perceived sleep quality and disturbances over the past 7 days. The 6-item Sleep Disturbance short form (6a) evaluates aspects such as difficulty falling asleep, staying asleep, and overall sleep satisfaction, while an additional question captures average sleep duration. Scores provide insight into sleep problems that may affect health and functioning.
Time frame: Week 0, Week 4, Week 8, Week 20
Whole Person Health Index (WPHI)
The WPHI is a simple self-report survey tool that provides a comprehensive snapshot of a person's health. The WPHI can serve as an anchor or reference point for connecting diverse health data, all while keeping the individual's personal health perspective at its core. The WPHI is based on nine questions developed and validated through a collaboration between the National Center for Complementary and Integrative Health (NCCIH) and the National Center for Health Statistics/Centers for Disease Control and Prevention.
Time frame: Week 0, Week 4, Week 8, Week 20
Patients Endorsement of a Biopsychosocial Model of Chronic Pain Scale (PEB)
A questionnaire to assess participant agreement with the biopsychosocial model of pain. The PEB is designed to assess patient beliefs about the biopsychosocial model of chronic pain. It has been previously shown to have good internal consistency and reliability and it has been recommended for use in longitudinal study designs for assessing patients' attitudes towards long-term pain management.
Time frame: Week 0, Week 4, Week 8, Week 20
World Health Organization Quality of Life Questionnaire - 2 (WHOQOL-2)
The WHOQOL-2 is a brief, validated instrument developed by the WHO to assess an individual's perceived quality of life across multiple domains, including physical health, psychological well-being, social relationships, and environment. It provides a global measure of overall life satisfaction and well-being.
Time frame: Week 0, Week 4, Week 8, Week 20
Patient Health Questionnaire - 8 (PHQ-8)
The PHQ-9 is a widely used self-report instrument for assessing the presence and severity of depressive symptoms over the past two weeks. The PHQ-8 excludes the item on suicidal ideation found in the PHQ-9, making it suitable for general population surveys and clinical research where suicide risk assessment is conducted separately.
Time frame: Week 0, Week 4, Week 8, Week 20
Generalized Anxiety Questionnaire-7 (GAD-7)
The GAD-7 is a brief, validated self-report questionnaire used to screen for and assess the severity of generalized anxiety disorder symptoms. It consists of seven items asking respondents how often they have been bothered by anxiety-related problems over the past two weeks. Scores help categorize anxiety severity from minimal to severe and assist clinicians and researchers in monitoring anxiety symptoms and treatment response. The GAD-7 is widely used in both clinical and research settings for its reliability and ease of administration.
Time frame: Week 0, Week 4, Week 8, Week 20
Treatment Self-Regulation Questionnaire (TSRQ)
The TSRQ is a validated self-report measure designed to assess individuals' motivation behind engaging in health-related behaviors. It evaluates the degree to which behavior change is driven by autonomous (intrinsic) versus controlled (extrinsic) motivation, grounded in Self-Determination Theory. The TSRQ helps identify the reasons patients choose to adhere to or modify treatments, providing insights into their internalization of health goals. It is commonly used in research to understand motivational factors influencing treatment adherence and lifestyle changes.
Time frame: Week 0, Week 4, Week 8, Week 20
International Physical Activity Questionnaire (IPAQ)
The IPAQ is a 12-question validated tool designed to capture information about a range of physical activity frequency, intensity, time, and type. The IPAQ has been shown to have high repeatability, with 75% of the Spearman correlation coefficients observed in a 12-country validation study to be above 0.65 and ranging from 0.88 to 0.32. The IPAQ also demonstrated high criterion validity ranging from 0.14 to 0.53, with a median of about 0.30. Reliability and validity have also been assessed in other languages and populations both healthy and unhealthy.
Time frame: Week 0, Week 4, Week 8, Week 20
Five Facet Mindfulness Questionnaire (FFMQ)
A questionnaire to assess participants trait mindfulness. The FFMQ is a self-report questionnaire that assesses trait mindfulness using five categories of mindfulness: Observing, Describing, Acting with Awareness, Nonjudging of inner experience, and Nonreactivity to inner experience. The FFMQ has demonstrated good construct, discriminant, and predictive validity, as well as its internal consistency.
Time frame: Week 0, Week 4, Week 8, Week 20
Mindful Reappraisal of Pain Scale (MRPS)
A questionnaire to assess participants pain reappraisal. The MRPS is a self-report questionnaire designed to quantify mindful reappraisal of pain. This survey is measured on a scale from 0, "never do that," to 6, "always do that". It was found to have good convergent and discriminant validity with various other mindfulness questionnaires and be sensitive to change in participants undergoing mindfulness interventions.
Time frame: Week 0, Week 4, Week 8, Week 20
Multidimensional Assessment of Interceptive Awareness - Version 2 (MAIA-2)
A questionnaire to assess interoception. The MAIA-2 is designed as a tool to assess interoceptive awareness. It is made up of eight subscales including: noticing, not-distracting, not-worrying, attention regulation, emotional awareness, self-regulation, body listening, and trust. It has been previously evaluated with internal consistency, validity, and reliability.
Time frame: Week 0, Week 4, Week 8, Week 20
Purpose in Life Scale
The Purpose in Life Scale is a self-report instrument designed to assess an individual's sense of meaning, purpose, and direction in life. It measures the extent to which a person feels their life has meaning and goals that give motivation and fulfillment. This scale is commonly used in psychological and health research to evaluate well-being, resilience, and overall mental health. Higher scores indicate a stronger sense of life purpose, which is associated with better psychological outcomes and coping abilities.
Time frame: Week 0, Week 4, Week 8, Week 20
PROMIS Physical Functioning Short Form 6b
The PROMIS Physical Functioning Short Form 6b is a brief, validated patient-reported outcome measure that assesses an individual's ability to perform everyday physical activities. It includes six items focused on mobility, self-care, and upper extremity function, capturing the impact of health conditions on physical functioning. Scores provide a standardized assessment of physical capabilities, with higher scores indicating better physical function. This tool is widely used in clinical and research settings to monitor physical health status and track changes over time.
Time frame: Week 0, Week 4, Week 8, Week 20
Actigraph LEAP 2.0
Biometric tracking will take place via the wearing of an actigraphy device. The device will track activity level and several parameters of sleep. This is a research grade actigraphy device. All participant data will be uploaded to a secure platform stored exclusively on a computer at Helfgott Research Institute. Only participant study IDs will be used within the data collection platform.
Time frame: Daily
Michigan Visual Aversion Stress Test (M-VAST 3)
Visual Stressors will probe mechanisms of global or generalized sensory sensitivity that bypass somatic peripheral receptors and the spinal cord, and are increased in many chronic pain patients. For visual testing, participants will be presented with a flashing annular checkerboard pattern at varying illumination levels as performed previously. Participants will be acclimated to a dark room and exposed to a high resolution, calibrated LED monitor displaying the visual stimulus. Each visual stimulus intensity level and the entire task will be rated on both sensory intensity and unpleasantness scales with overall task ratings and stimulus-response curves generated for analysis. Participants who report being diagnosed with or self-report visual-evoked migraines will not participate in the visual testing.
Time frame: Week 0, Week 8
Algometry (Pressure Pain Threshold) - Wagner FPX-25
Objective measure of pain to assess participants' response to pressure. Algometers are designed to quantify and document levels of tenderness via pressure pain threshold measurement and pain sensitivity via pressure pain tolerance measurement. Overall, digital algometers have been shown good validity in patients with migraine and low back pain.
Time frame: Week 0, Week 8
Pinprick (Mechanical Pain Threshold)
Pinprick testing assesses mechanical pain threshold (MPT), a measure of nociceptive sensitivity to punctate mechanical stimuli. Standardized, weighted pinprick stimulators, 256 millinewtons will be applied perpendicularly to the skin at a non-painful site (volar forearm or upper trapezius, lower back, and the area of most pain). This test is used to evaluate central sensitization. Pinprick testing is non-invasive, well-tolerated, and commonly included in quantitative sensory testing (QST) protocols to assess changes in mechanical pain sensitivity.
Time frame: Week 0, Week 8
Stroop Color Word Task (SCWT)
The SCWT is used to measure a person's attentional interference or the ability to inhibit the interruption of a second stimulus while continuing to process an original stimulus. The SCWT will be conducted online using the Testable platform. In the SCWT, the words RED, YELLOW, and BLUE will be presented in one of the alternate font colors and the participant will be asked to press the first letter of the font color on a keyboard rather than the color of the word itself.
Time frame: Week 0, Week 8
Conity Motion Analysis System
Motion assessments of the lumbar spine will be performed using the Conity system which uses commercially available IMU sensors that are designed for collecting human kinematics non-invasively.
Time frame: Week 0, Week 8
Plan to share: Yes — The data that support the findings of this study are available from the corresponding author, R.S.W., upon reasonable request.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: June 2027-
Access criteria: The data that support the findings of this study are available from the corresponding author, R.S.W., upon reasonable request.
Started Aug 2025 (actual). Primary completion is estimated for Nov 2026, 15 months after the start.
Of 44 non-industry interventional studies with no phase under Sciatica, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 30. This study's planned 15 months is above that.
Counting every sponsor, half of 44 studies reached it within 11 months; a quarter within 6 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
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